A Phase III Study of GS101 Injection to Dupixent®
ConditionAtopic Dermatitis (AD)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Genscend Biopharmaceutical Co., Ltd
About this trial
This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®
Eligibility criteria
Qualifiers
Subjects, male or female, between the ages of 18 and 75 years (inclusive)
At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening
During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.
Disqualifiers
Hypersensitivity or known allergy to the investigational product(s) or any of their excipients
Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer
Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period
Trial design
Treatments tested in this trial
- GS101 injection
- DUPIXENT®
Treatment groups
572 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov